Thank youkitovpharma.investorroom.com/download/Kitov+Corp+June...strategies and objectives of management for future operations; product development for NT219 and CM-24; the potential

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Corporate Presentation

June 2020

Forward-Looking Statements and Safe Harbor

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Certain statements in this presentation that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private

Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, the intended use of proceeds and statements that are not statements of historical fact, and may be

identified by words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations

of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. You should not place undue reliance on these forward-looking statements, which

are not guarantees of future performance. Forward-looking statements reflect our current views, expectations, beliefs or intentions with respect to future events, and are subject to a number of

assumptions, involve known and unknown risks, many of which are beyond our control, as well as uncertainties and other factors that may cause our actual results, performance or achievements to be

significantly different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause or contribute to such differences

include, among others, risks relating to: different results from the expected benefits, synergies and costs of the acquisition of FameWave by Kitov; management plans relating to the transaction; the plans,

strategies and objectives of management for future operations; product development for NT219 and CM-24; the potential future financial impact of the transaction; and any assumptions underlying any of

the foregoing; the process by which early stage therapeutic candidates such as NT219 and CM-24 could potentially lead to an approved drug product is long and subject to highly significant risks,

particularly with respect to a joint development collaboration; the fact that drug development and commercialization involves a lengthy and expensive process with uncertain outcomes; our ability to

successfully develop and commercialize our pharmaceutical products; the expense, length, progress and results of any clinical trials; the lack of sufficient funding to finance the clinical trials; the impact of

any changes in regulation and legislation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals necessary in order to commercialize our products; the difficulty of

predicting actions of the U.S. Food and Drug Administration or any other applicable regulator of pharmaceutical products; the regulatory environment and changes in the health policies and regimes in the

countries in which we operate; the uncertainty surrounding the actual market reception to our pharmaceutical products once cleared for marketing in a particular market; the introduction of competing

products; patents attained by competitors; dependence on the effectiveness of our patents and other protections for innovative products; our ability to obtain, maintain and defend issued patents with

protective claims; the commencement of any patent interference or infringement action; our ability to prevail, obtain a favorable decision or recover damages in any such action; and the exposure to

litigation, including patent litigation, and/or regulatory actions, and other factors that are discussed in our in our Annual Report on Form 20-F for the year ended December 31, 2019 and in our other filings

with the SEC, including our cautionary discussion of risks and uncertainties under ‘Risk Factors’ in our Registration Statements and Annual Reports. These are factors that we believe could cause our actual

results to differ materially from expected results. Other factors besides those we have listed could also adversely affect us. Any forward-looking statement in this press release speaks only as of the date

which it is made. We disclaim any intention or obligation to publicly update or revise any forward-looking statement, or other information contained herein, whether as a result of new information, future

events or otherwise, except as required by applicable law. You are advised, however, to consult any additional disclosures we make in our reports to the SEC, which are available on the SEC’s website,

http://www.sec.gov.

Kitov Pharma (NASDAQ/TASE:KTOV)

A clinical-stage company

advancing first-in-class

oncology therapies

Two novel assets targeting significant unmet needs

Strong partners and collaborators

Consensi™: Commercial stage drug to support pipeline

development

> $28M-36M of revenues expected in 2020-2022

Institutional healthcare focused investors

Financials:

Market cap. $50M*

$29M cash as of January 1st, 2020 (pro forma**)

13M shares 3-month avg. trading volume

* As of June 5th , 2020** including net $24M raised since January 2020 in financing activities

CM-24 – Inhibitor of CEACAM1

NT-219 – Dual inhibitor of IRS 1/2 and STAT3

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Program Indication Preclinical Phase 1 Phase 2 Phase 3 Partners Value Drivers

CM-24NSCLC and Pancreatic Cancer (combination with nivolumab) (Clinical Collaboration)

Study initiation Q4:20Phase 1 data H1:21

NT-219R/M solid tumors and Head and Neck (monotherapy and

in combination with Erbitux®)

IND clearedStudy initiation Q2:20Phase 1 data H1:21

From Development to Commercialization

Multiple data read-outs expected within 15 months

Product Indication Status Partners

CONSENSI™Simultaneous treatment of

osteoarthritic pain and hypertension

Approved for marketing by U.S. FDA

U.S.: Coeptis PharmaceuticalsChina: CSBioS. Korea: Kuhnil Pharmaceutical

Experienced Leadership

Eric K. Rowinsky, MDChairman of the Board Formerly CMO at ImClone, Stemline, Board member at Biogen Inc.

Isaac Israel Chief Executive Officer Formerly CEO of BeeContact Ltd. (TASE:BCNT), NextGen Biomed (TASE: NXGN)

Bertrand Liang, MD, PhD, MBA, AMP Chief Medical OfficerFormerly at Biogen Idec, Amgen, NCI

Gil EfronDeputy CEO and Chief Financial Officer Formerly CFO at Kamada (NASDAQ:KMDA)

Hadas Reuveni, Ph.D.Vice President, Research and DevelopmentFormerly at Keryx (NASDAQ:KERX)

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Michael Schickler, Ph.DHead of Clinical Operations Formerly at Hoffmann-La Roche, CEO at CureTech,

Advancing First-in-Class Oncology Therapies

CM-24 – Inhibitor of CEACAM1

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• CEACAM1 (Carcinoembryonic Antigen Cell

Adhesion Molecule 1) - member of the

Human CEA Family

• Interacts with both CEACAM1 and CEACAM5

• Regulates TIM-3-mediated tolerance and

exhaustion*

• High expression in tumor and in tumor-

infiltrating immune cells

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Bladder carcinoma Colon

Pancreas

Melanoma (70%) Bladder (96%)

Colon (92%) Pancreas (94%)

Lung (50%) Gastric (74%)

Prostate (63%)

*Gray-Owen and Blumberg, CEACAM1: contact-dependent control of immunity, Nature Review Immunology , 2006, DOI: https://doi.org/10.1038/nri1864

%CEACAM1 staining in tumor CEACAM1 + Immune cells

CEACAM1 Plays a pivotal role in the immune system

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Markel et al, J Immunol 2002, 2006; Immunology, 2008; Cancer Immunol Immunother 2010; Ortenberg et al, Mol Cancer Ther 2012; Zhou, 2009; Li, 2013; Huang, 2015

CM-24 MOA: Blocks CEACAM1-mediated interactions

• CM-24 is a humanized IgG4 mAb highly specific to the

extracellular domain of CEACAM1 with Nano-molar affinity

• CM-24 prevents CEACAM1-CEACAM1 or CEACAM1-

CEACAM5 interaction, thus enhancing the cytotoxic activity

of the lymphocytes

• CM-24 activity is manifested in the blockade of:

– Immune inhibitory signals

– Angiogenesis

– Tumor-stroma interaction

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• Xenograft, lung lesion, Mel 526 (IV)

• Tumor burden was monitored 26 days post last CM-24 treatment

TIL + IgG

TIL + CM-24

Naive

Combination index (CI) = 0.15

< 1 synergism

Anti-Cancer Effect Following Treatment with CM-24 + TIL and CM-24 + Anti-PD1

Significant benefits as both single agent and in combination with α-PD-1

CM-24 Phase 1 Monotherapy Trial

• Open-label, multi-dose escalation study to assess safety and tolerability of CM-24

• Conducted by Merck in 4 US centers: UCLA, Yale; Israel: Sheba, Sourasky

• Heavily pre-treated patients with a median of 3 prior regimens (range 2-7) and a median of 4 prior regimens at the 3mg/kg & 10mg/kg doses

No DLTs up to 10 mg/kg

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Overall, treatment with CM-24 was well tolerated

No discontinuation of study drug due to an AE No drug related mortalities 29.6% SD (RECIST)

Q2wks x 206-weekobservation

0.3 mg/kg

1.0 mg/kg

3.0 mg/kg

10.0 mg/kg

0.01mg/kg

0.03mg/kg

0.1 mg/kg

1

3

3

3

7

1

9

q2wks X 4

27 patients:

Colorectal 11

Melanoma 7

Ovarian 4

Gastric 3

NSCLC 2

PK/PD Modeling Suggests Saturation KineticsHigher Doses and Shorter Schedule Required

Simulated TMDD saturation at Ctrough with Q2W regimen Predictions with Q3W regimen (not clinically tested)

• Keytruda®’s administration regimen is Q3W

• With Q3W, 10 mg/kg is predicted to achieve only > 50% saturation

• Consistent with observed PK showing high clearance at doses <10 mg/kg, plot shows low TMDD saturation at low doses

• 10 mg/kg approaches > 90% saturation but >10 mg/kg dose is needed for saturation across population

OPDIVO® is administered Q2W or Q4W, and thus represents a better clinical and commercial fit for CM-24 than KEYTRUDA®

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KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., OPDIVO® is a registered trademark of Bristol-Myers Squibb.

Market opportunity: Non-Small Cell Lung Cancer

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• CEACAM1 expression correlates with poor prognosis in NSCLC*

• Preclinical data supports significant synergism

• Receptor saturation with CM-24 is better achieved with a Q2W regimen and is aligned with the Opdivo® protocol

• Collaboration with Bristol-Myers Squibb, a leader in Immuno-Oncology (I/O) research, to address an urgent need

Rationale for combining Opdivo® + CM-24

Targeting the unmet medical need• Non-small cell lung cancer accounts for 85% of all lung cancer diagnoses, approx. 193,927 new cases/year; with a 5-year

relative survival rate of 23%**

• Immunotherapy is now recommended as first line therapy in all patients with NSCLC and no driver mutations***

• 5-year overall survival rates with chemotherapy in 2L is 2.6% and with I/O Opdivo® is 13.4%****

Opdivo® + CM-24 has the potential to provide long lasting effective treatment

* Dango et al, Lung Cancer 2008; 60:426**American Cancer Society, Cancer Facts & Figures 2019, and the ACS website***Economopoulou P, Mountzios G. The emerging treatment landscape of advanced non-small cell lung cancer. Ann Transl Med. 2018;6(8):138. doi:10.21037/atm.2017.11.07**** Gettinger S, et al "Five-year outcomes from the randomized, phase III trials CheckMate 017/057: Nivolumab vs docetaxel in previously treated NSCLC" WCLC 2019; Abstract OA14.04.

CM-24 Phase 1/2 Study Design

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• A Phase 1/2 open label multi center study of CM-24 in combination with nivolumab (Opdivo®) in selected cancer indications (Phase 1), NSCLC and Pancreatic cancer (Phase 2)

• Clinical collaboration with Bristol-Myers Squibb

• Measurement of CEACAM1 based bio-marker

Primary endpoints:

Phase 1: Evaluate the safety, PK and the MTD/RP2 dose

Phase 2: Evaluate preliminary efficacy in 2nd line NSCLC and pancreatic cancer

• Exploring further studies in other tumor types as well as monotherapy

CM24 (@MTD) + nivolumab (240mg) q2wI/O refractory NSCLC; 2nd line

n=13+14 (Simon 2 Stage Optimal Design)

Q1:20 Q2 Q3 Q4 Q1:21 Q2 Q3 Q4 Q1:22 Q2 Q3 Q4 Q1:23 Q2 Q3 Q4 Q1:24 Q2

CM24 (@MTD) + nivolumab (240mg) q2w+ SOC chemotherapy

Locally advanced, unresectable pancreatic cancer; 2nd line

n=13+14 (Simon 2 Stage Optimal Design)

Doses: 10, 15, 20mg/kg q2wk

+ nivolumab (240mg q2wk)

3+3 design; 9<n<18

Indications: NSCLC, Pancreatic, CRC,

Melanoma, Papillary Thyroid Carcinoma

Dose Escalation Expansions

Advancing First-in-Class Oncology Therapies

NT219 – Dual inhibitor of IRS 1/2 and STAT3

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IRS1/2

IRS1/2 and STAT3 Role in Cancer Drug Resistance

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STAT3

• Part of the IGFR complex • Phosphorylated on tyrosine residues and triggers

activation of PI3K/AKT and MEK/ERK signaling pathways

• Regulates cell proliferation, protein synthesis, survival, gene expression and apoptosis

• Active in the JAK/STAT3 immune evasion mechanism of the tumor

• Provides a crucial axis to support cell proliferation and survival

Drug resistance

Feedback

STAT3

TUMOR PROGRESSION

IRS

TUMORPROGRESSION

AKT

Feedback

ONCOPROTEIN

DRUG

MEK / ERK

IRS1/2 and STAT3 are key signal transducers activated as a feedback response to anti-cancer drugs, leading to drug resistance

NT-219 MOA: Inhibition of Both STAT3 and IRS is Required to Overcome Resistance

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STAT3 IRS

EGFR

MEK

TumorRegression

Erlotinib

ERK

PI3K

AKT

TumorSurvival

TumorSurvival

BuparlisibRuxolitinib

Overcoming drug resistance

NT219 NT219

STAT3 IRS

ONCOPROTEIN

DRUG

MEK / ERK

TUMOR REGRESSION

By blocking both STAT3 and IRS resistance pathways, NT-219 prevents tumor resistance and re-sensitizes tumors to anti-cancer therapies

Proof of Concept: PDX model of Head and Neck Cancer

NT219 - Efficacy as Monotherapy and in Combination with Erbitux®

Animal modelHead & Neck Cancer (SCC-9) NSG™ PBMCs

DrugsCetuximab (Erbitux®)NT219 20mg/kg

NT219 60mg/kg

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* Adapted from 2020 Multidisciplinary Head and Neck Cancers Symposium Poster presentation

Market Opportunity: Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)

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• EGFR and PD(L)-1 are the only clinically validated targets in SCCHN

• Cetuximab inhibits EGFR signaling and promotes ADCC in EGFR expressing tumors

• STAT3 and IRS-to-AKT activation contributes to resistance to cetuximab in HNSCC

* Global Data 2018: Head and Neck Squamous Cell Carcinoma: Opportunity Analysis and Forecasts to 2026** Internal best current estimates of patient numbers based on external research, 5 major global territories

Rationale for combining Cetuximab + NT-219

Targeting the unmet medical need• 1L Standard of care is shifting from chemotherapy

towards immuno-oncology + chemotherapy*

• Only < 20% of R/M SCCHN patients respond to anti-PD1s

• Number of new cases/year is expected to be 174,000 by 2024

1L 2L 3L60k** 24k** 13k**

IO + CTIO Mono

orCetuximab

NT-219

Cetuximab

NT-219 + cetuximab has the potential to become an attractive 2-3L therapy

NT-219 Phase 1/2 Study Design

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Title: A phase 1/2 study with open-label, dose escalation phase followed by single-arm expansion to assess the safety, tolerability, PK, PD and efficacy of NT219, alone and in combination with Erbitux® (cetuximab) in adults with recurrent or metastatic solid tumors and Head and Neck cancer

• Primary endpoint: Safety, pharmacokinetics and to determine the MTD

• Secondary endpoint: Obtain preliminary efficacy data

Dose Escalation NT219 q1w

18<n<30

ExpansionNT219 q1w @ RP2D

n=11+18 (Simon 2 stage design)

Q1:20 Q2 Q3 Q4 Q1:21 Q2 Q3 Q4 Q1:22 Q2 Q3 Q4 Q1:23 Q2 Q3 Q4 Q1:24 Q2 Q3

Topline Results

Topline Results

Dose Escalation NT219 q1w + cetuximab q1w

9<n<18

NT219 as a single agent in subjects with R/R solid tumors

NT219 + cetuximab in subjects with R/M Head and Neck cancer*

ExpansionNT219 q1w + cetuximab q1w

n=11+18 (Simon 2 stage design)

= Indication TBD (expansion not part of the study protocol)

* Colorectal Adenocarcinoma pts will be recruited in the Dose Escalation phase

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Kitov Commercial Drug: CONSENSI™

• Approved for marketing by U.S. FDA on May 31, 2018

• Clinical data showed Consensi™ was more effective at lowering blood pressure than amlodipine alone

• Clinical data also demonstrated beneficial renal function measures

• Formulated with 200 mg celecoxib and three different dosages (2.5, 5, 10 mg) of amlodipine

• Manufactured by Dexcel Pharma – Israel’s largest private pharmaceutical company

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Simultaneous treatment of osteoarthritic pain and hypertension

Fixed dose combination of Celecoxib, a COX-2 selective NSAID (the active ingredient in Pfizer’s

Celebrex®)

+Amlodipine, a blood pressure-lowering agent (a calcium channel blocker) (the active ingredient in

Pfizer's Norvasc®)

*Celebrex® is a registered trademark of G.D. Searle LLC (a subsidiary of Pfizer Inc.). Norvasc® is a registered trademark of Pfizer Inc.

CONSENSI™ is the only NSAID whose labeling indicates reduction of blood pressure and consequent risk reduction of heart attack, stroke and deathFull U.S. Prescribing Information is available at: : http://www.consensi.com

CONSENSI™ U.S. target markets

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CONSENSI™ targets osteoarthritis (OA) patients currently treated with NSAIDs (celecoxib as well as others) who also suffer from existing or newly diagnosed hypertension

OSTEOARTHRITIS50 million patients*

NSAIDs

60%

of all OA Rxs

* Arthritis Foundation: http://www.arthritis.org/ ** Hypertension Among Adults in the United States: National Health and Nutrition Examination Survey, 2011–2012

ARTHRITIS PREVALENCE*

• More than 50 million adults in the U.S. have doctor-diagnosed osteoarthritis

• 67 million people are expected to have doctor-diagnosed osteoarthritis by 2030

HYPERTENSION PREVALENCE**

• 29% of U.S. adults older than 18

• 65% of U.S. adults older than 60

COMORBIDITIES

• 44% of adults with high blood pressure have osteoarthritis**

HYPERTENSION

Celecoxib

24%

of all NSAIDs Consensi™

CONSENSI™ commercialization partners

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South Korea - Exclusively licensed toKuhnil Pharmaceuticals (March 2017)

U.S. - Exclusively licensed to Coeptis Pharmaceuticals. Milestone payments up to

$99.5M, 20% royalties (January 2019)

China - Exclusively licensed toChangshan Pharma. Milestone

payments up to $9.5M, double-digit royalties (May 2018)

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Milestones

Q2 2020

Q2 2020

Q2 2020

Q3 2020

Q42020

NT-219 IND clearance

NT-219 Initiation of phase 1/2

clinical study

NT-219 Collaboration

agreement with potential

strategic partner

CONSENSI™ U.S. launch

CM-24

INDamendment

clearance

CM-24 Initiation of a phase 1/2 clinical study in collaboration with

Bristol Myers-Squibb

Q2 2020

Kitov Pharma (NASDAQ/TASE:KTOV)

A clinical-stage company

advancing first-in-class

oncology therapies

Two novel assets targeting significant unmet needs

Strong partners and collaborators

Consensi™: Commercial stage drug to support pipeline

development

> $28M-36M of revenues expected in 2020-2022

Institutional healthcare focused investors

Financials:

Market cap. $50M*

$29M cash as of January 1st, 2020 (pro forma**)

13M shares 3-month avg. trading volume

* As of June 5th, 2020** including net $24M raised since January 2020 in financing activities

CM-24 – Inhibitor of CEACAM1

NT-219 – Dual inhibitor of IRS 1/2 and STAT3

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Thank you

We are committed to providing cancer patients with

first-in-class therapies to OVERCOME tumor drug resistance,

ENHANCE treatment response and SLOW tumor progression

Contact us: Email: [email protected]

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Appendix A - CM24

Inhibition of Melanoma Growth Following CM-24 and CM24 + TIL TreatmentCM-24 activity is demonstrated as single agent and in combination with TILs

*P<0

.05

TG

I 71

%*

P<0

.05

TG

I 45

%

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Phase 1 PK Data Saturation was not reached with doses up to 10mg/kg

Slower clearance with increasing dose

Higher half-life with increasing dose

0.1 mg/kg 0.3 mg/kg 1 mg/kg 3 mg/kg 10 mg/kg

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Appendix B - NT219

NT219 Re-sensitizes Tumors to Anti-PD1

30* Double autologous model - Tumors & PBMCs are from the same patient (#RA236) | Keytruda - 6mg/kg IP, NT219 - 60mg/kg IV

PDX model

Humanized PDX of Esophagus Cancer

Drug

Pembrolizumab (Keytruda®)

NT219 Overcomes Resistance to Gemcitabine in Pancreatic Cancer PDX Models

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PDX model

Pancreatic Cancer

Drug

Gemcitabine (Gemzar®)

Additional newly released data for NT-219 in reversing Pancreatic Cancer drug resistance is available on AACR PanCan poster: http://kitovpharma.investorroom.com/index.php?s=151

RNAseq Analysis of Tumors Following Treatment Confirming NT-219 Mechanism of Action

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PDX model

Pancreatic Cancer

Drug

Gemcitabine (Gemzar®)

Selected Publications

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MenasheBar-Eli

MichaelKarin

MichaelCox

AlexanderLevitzki

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Appendix C - CONSENSI™ Clinical Data

CONSENSI™ Medical Rationale

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Celecoxib (the active ingredient in Pfizer's Celebrex®)

• The only widely prescribed selective COX-2 NSAID approved in the U.S. (unlikenon-selective NSAIDs, celecoxib carries limited gastrointestinal risks)

• Since 2005, has an FDA-mandated “black box” label warning of increasedcardiovascular risks

• According to FDA, cardiovascular risks can occur as early as the first few weeks ofusing an NSAID, and may increase with longer use

Amlodipine (the active ingredient in Pfizer's Norvasc®)

• Calcium channel blocker; anti-hypertensive

• Unlike other blood pressure-lowering drug groups – such as diuretics, ACEinhibitors, and angiotensin II receptor antagonists – calcium channel blockers donot cause deterioration of renal function, including possible acute renal failure*

* The FDA Safety Information and Adverse Event Reporting Program; http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm270998.htm

CONSENSI™ Phase III Trial Design

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Demonstrate that the reduction in blood pressure in the Consensi™ arm is at least 50% of the reduction in the amlodipine arm

Measurement of pain was not required by FDA

Primary endpoint

Newly diagnosed

hypertensive patients

Data Collection

and Statistical Analysis

Double-blind, placebo-

controlled, multi-center study

N = 152

4-arm trial with 30-45 patients in

each arm

2 weeks of treatment

Consensi™

CONSENSI™ Phase III Trial Results

• Primary efficacy endpoint was successfully achieved (P=0.001)

• Demonstrated 2.5x better blood pressure reduction than FDA requirement (50% of amlodipine arm)

• Demonstrated consistent reduction in all measures of blood pressure

• Observed beneficial renal functions:

• Additional Phase III/IV clinical trial to scientifically validate the renal benefits (not required for NDA submission) was completed. Topline results were announced in October, 2017

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* Error bars – standard error of mean

Blood Pressure Reduction of Consensi™ vs. Amlodipine and Celecoxib*

Consensi™ demonstrated even better BP reduction than same amount of amlodipine given without celecoxib

Measure Consensi™ Amlodipine

Creatinine plasma level reduction

-3.22 μmol/L

-2.55 μmol/L

Peripheral edema (% patients)

8.2% 15.6%